Healing Earth and its role in gastrointestinal diseases: influence of treatmentwith Luvos® Heilerde on the intestinal microbiome in healthy individuals, inpatients with irritable bowel syndrome (IBS) and in patients with liver cirrhosisand concomitant minimal hepatic encephalopathy – the ARENA - Trial

Recruiting

Conditions: K58
K74
Irritable bowel syndrome
Fibrosis and cirrhosis of liver

Registration Number: DRKS00032274

Lead Sponsor: Klinikum der Universität München, Campus Großhadern

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 44

Inclusion Criteria

Diarrhea-predominant IBS patients according Rome IV criteria
- Patients with liver cirrhosis and minimal hepatic encephalopathy
- Healthy controls without diagnosis of functional gastrointestinal
diseases, neurodegenerative diseases, tumor disease in the last 5 years, severe metabolic or cardiovascular disease requiring therapy

Exclusion Criteria

1. Documented underlying allergic condition against Healing Earths
2. Antibiotic treatment within 28 days before study entry or during the study
3. Individuals who are not in sufficient health status as determined by the
outcome of medical history, physical assessment, and clinical judgment of
the investigator
4. Individuals who are not able to follow the required study procedures for the entire period of the study
5. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject´s ability to participate in the trial.
6. Individuals who are planned to be hospitalized or undergo bowel cleansing or major surgery during the study period
7. Female subjects with childbearing potential who have positive pregnancy
test during screening period. Pregnant and lactating women

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analysis of the intestinal microbiome in healthy individuals (ARENA 1), in<br>IBS patients with predominant diarrhea (IBS-D) (ARENA 2) and in<br>patients with liver cirrhosis with concomitant minimal hepatic<br>encephalopathy (ARENA 3) before, during and after consumption of<br>Luvos Healing Earth.

Secondary Outcome Measures